ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER— 510(k) K002627

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K002627 for ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER, Substantially Equivalent on 2001-04-26. Applicant: Atrium Medical Corp..

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 2000-08-23
Decision date: 2001-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.